Q1 2022 PDS Biotechnology Corp Earnings Call
Hello, and welcome to the P. D S biotechnology first quarter 2022 earnings call and webcast. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.
It's now my pleasure to turn the call over to Gabby D. Griffin. Please go ahead.
Good morning, and welcome to P. D. S. Biotechnologies first quarter 2022 earnings conference call.
A webcast with me today from the company are Doctor Frank I do I do Chief Executive Officer, Dr. Lawrence He was Chief Medical Officer, and Dot Hill, Chief Financial Officer.
Earlier this morning P. D S biotech issued a press release announcing financial results for the quarter ended March 31st 2022.
We encourage everyone to read the press release as well as P. D. S. Biotechs report on Form 10-Q, which was filed with the SEC earlier this morning.
The company's press release is available on the P. D. S website at P. D S biotech dotcom and the 10-Q should be posted later today. In addition, this conference call is being webcast and will be archived on the company web site for future reference.
Before we begin we need to remind everyone that on today's call. The company will be making forward looking statements regarding regulatory and product candidate development plan as well as research activities.
These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
A description of these risks can be found on P. B S. Biotechs, most recent filings with the SEC.
You are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this conference call.
But to the extent required by applicable law or regulation P. D. S. B undertakes no obligation to update the forward looking statements include it today to reflect subsequent events or circumstances.
As you can see where are you seeing a different format for the earnings call today, relying on flights to help summarize programs and milestones and any just streamline the presentation of background information and updates.
I know your time is a precious commodity and we want to leave as much time as possible for Q&A. Your feedback on this new structure would be welcome with that I would now like to turn the call over to Frank Frank.
Thank you Debbie and thanks to all of you for joining us this morning.
Before we get into the details of our recent achievements and financial results.
We thought it would be helpful to give a brief review of our platforms and pipeline to put our accomplishments into context.
We are also providing some visuals to eight hour discussion.
For those of you who may be new to the story.
A quick refresher our pipeline is built on two proprietary T cell activating platform versus meal on which on expanding pipeline of clinical and preclinical molecularly targeted immuno oncology candidates are based.
And in fact, many of them on which our advancing preclinical infectious disease pipeline is based.
Diverse means platform allows us to administer tumor specific proteins by subcutaneous injection, resulting in powerful Dth killer T cell responses against the cancer.
The infecting on technology, it's administered predominantly by intramuscular injection and results in both pathogen specific T cell and antibody responses.
P. D. S. Biotech is developing multiple molecularly targeted cancer immunotherapy candidate such as our lead product P. D. S O one O one.
P. S O. One O one has been demonstrated in ongoing studies.
Cancers that express all contained HPV.
And it's agnostic to the anatomic location of the cancer.
These diverse immune based immunotherapies, therefore have the potential to treat a broad range of cancer types.
With almost versus new platform, we seek to lead a transformation in the treatment of cancer to what's not only more effective but also potentially safer therapy.
We believe that we are well on our way to doing so.
With our in fact immune technology, we seek to lead the development of more broadly protective vaccine.
As seen in the preclinical results reported with our universal flu vaccine.
Yeah.
Here, we provide a broad overview of ongoing studies with our lead versus mean based candidate P. B S O one O one.
Which is being evaluated in four phase two clinical trials.
As a combination treatment in advanced and refractory cancers and also in locally advanced cancer.
In early stage cancer P. D. S O. One O. One is also being evaluated as a monotherapy.
Tds <unk> hundred one is a molecularly targeted immunotherapy that can be studying across the full spectrum of HPV related cancers.
This I mean that we are studying P. D. S O. One O one in all types of HPV associated cancers, including AML.
That'd be cool head and neck, penile vaginal and follow up of cancers.
Secondly, we are studying these cancers at all stages of the disease from early stage cancer in a new in our new adjuvant trial led by Mayo clinic to advance the checkpoint inhibitor refractory cancer in our National Cancer Institute led trial.
We estimate this could create an aggregate market potential of $5 billion to $6 billion in the United States and Europe or P. D. S. A one to one.
Yeah.
We are conducting these trials in collaboration with some of the most renowned institutions in the field.
<unk> Cancer Institute Merck.
Merck M D Anderson cancer Center, and the Mayo clinic.
These strategic relationships have enabled P. B S biotech to achieve our goal of broadly covering but HPV cancer space.
These relationships have provided multiple additional benefits to PDF biotech.
Not only have they enhanced our expertise in this space.
But we believe they have facilitated enrollment in the clinical trial and importantly.
Through cost sharing agreements, we have mitigated much of the financial burden of rapidly advancing our clinical studies.
We are very excited the data from the first two studies listed here.
Our National Cancer Institute led Triple combination trial, and our versatile there was there were two trial will both be presented at this year's American Society of clinical oncology annual meeting Pascoe.
Turing from June 3rd.
The seven.
We believe this is a real testament to the quality of work being done by our team and our partners.
And we are very much looking forward to sharing visa efficacy and safety results publicly.
Do know that that accepted abstracts are scheduled to be published on May the 26.
On Tuesday June seven at eight a M. After our presentations we plan to host a conference call to further discuss the present the data from both trials.
We will issue a press release to announce this event.
Yeah.
Turning to trial updates.
Let's first review our Triple combination study.
In this trial, we are evaluating P. D. S. O 101 in combination with <unk> offer a bifunctional checkpoints inhibitor.
And 90 241 also known as N H S IL 12.
Two investigational immune modulating candidates owned by Merck K G. A a.
By combining three components that activate the immune system by complementary anti tumor mechanism. Our goal is to generate cancer targeting killer T cells, while successfully overcoming the immuno suppressive tumor environment.
The triple combination is being evaluated across the range of HPV positive advanced relapsed and refractory cancers that are well documented to be extremely difficult to treat and for which more effective therapies are desperately needed.
The data from this trial to be presented at <unk> will be a continuation of the study and data that was presented at Astro last year in both checkpoint inhibitor naive.
Checkpoint inhibitor refractory patients.
We expect an update on how the patients whose data was presented have fared over the last year.
Essentially how durable what's the anti cancer immune response.
What fraction of the patients remain alive.
Improving overall survival is one of the most important goals of cancer treatment.
Secondly, what does the overall responses, including the more recently enrolled enrolled patients look like.
We anticipate that in addition to the solid preclinical data demonstrating the key contribution of each of the three agents towards the observed strong anti tumor result.
But the F. D. A may expect some demonstration of the clinical contribution of each of the agents in the combination.
The role of P. D. S O one O one wasn't very clearly demonstrated in the early data.
To study the contribution of NHS IL 12, the National Cancer Institute is evaluating high and low doses of the drug.
And we expect that some of this data may also be presented at <unk>.
Yeah.
The preliminary efficacy data appears to support diversity and platforms potential unique ability to aid in the recruitment training and activation of large numbers of critical cancer attacking killer T cells in vivo, even in very ill patients.
We plan in the near future to initiate discussions with the FDA to align on the Registrational path.
Now turning to our versatile zero-zero two phase II trial, which is studying <unk> hundred one in combination with Merck and coast checkpoint inhibitor keytruda for Pembina lose them up in patients with HPV 16, positive metastatic and or recurrent head and.
That cancer.
As with the Triple combination trial. This trial has two study groups checkpoint naive patients in checkpoint refractory patients.
In this trial P. D. S. Biotech is seeking to improve clinical benefit or was that seen with keytruda monotherapy.
In addition to improved tumor shrinkage and overall survival. We believe that's a significant treatment advantage will be achieved if enhanced clinical benefit is attained without compounding or increasing the toxicity profile over what has been reported with Keytruda monotherapy.
In February of this year promising preliminary safety data were presented at the multi disciplinary head and neck cancers symposium.
None of the first 18 patients showed any treatment related grade three or higher toxicity.
This is extremely unusual for any cancer therapy, and particularly for a combination therapy.
To put the safety profile in perspective, I'll quickly refer to a news article in March out of the Hollings cancer Center at the medical University of South Carolina, one of the top head and neck cancer centers in the country.
Yeah.
The principal investigator on our study Doctor Cottesmore had enrolled its first patient onto the study in August of 2021.
The patient had a tumor myself about eight centimeters and signs off spread.
By March of 2022 the tumor had shrunk to two centimeters and the patient will support the truck continued to have a high quality of life through treatment.
To quote the customer.
The treatments involved in this trial, so far have been very tolerable, which is nice because sometimes investigative treatments can produce some side effects.
The main side effect of the study treatment, we've seen are some pain and readiness around the injection site and fatigue.
Yeah.
Do note that we have reported a small patient size of 18.
However, if this combination of efficacy and safety continues to be seen in a significant number of patients.
This approach of using the birth of immune T cell activating technology could be transformative in cancer treatment.
We look forward to presenting detailed efficacy data from the first up with Bristol 002 trial IOSCO.
Next let's spend a minute or two on our preclinical brisk immune based oncology programs.
P D S O one O three targets mucin, one for Mark one.
Given the presence of Mach one across several solid tumors. We believe PD is a one O three could have utility in the treatment of a broad range of cancers.
<unk> breast ovarian lung and colon cancers are very substantial global market.
We've previously discussed our positive preclinical data, which demonstrated P. S O one with <unk> ability to promote the induction of a large number of poly functional and highly potent Mach one specific.
C D H killer T cells.
Yeah.
The P. S O one of three antigens have been successfully manufacture.
And preliminary stability and Immunogenicity testing of the new clinical grade antigens in progress by Pdf's biotech as S process development for manufacture of the P. B S O one O three pharmaceutical product.
Following a recent positive pre IND meeting with the F D. A.
We continue to expect to file an IND for the program in the fourth quarter of 2022.
Yeah.
We've also continued to make progress on our top program P. D. S O one O two.
As you know late last year, we in licensed rights to the National cancer Institutes proprietary T cell receptor gamma alternate reading frame protein tumor antigen, abbreviated T a RFP or TARP.
Based on preliminary studies, we expect our candidates P. D S. A one or two to facilitate the generation of TARP specific C. D eighth killer T cells.
And may have utility in the treatment of both solid and liquid tumors, including a M L prostate and breast cancers.
Manufacturing efforts here are ongoing however, given all of our ongoing programs, we're not devoting significant resources to the TARP program and now expect clinical launch sometime in 2023.
Lastly, before passing it over to Matt I'd like to briefly discuss our in effect immune based infectious disease preclinical pipeline.
We believe that the key differentiating attributes of the infecting and platform technology are strong indication or strong induction of virus or pathogens.
Which can be reached to improve treatments and preventive options for several infectious diseases.
In January of 'twenty, 'twenty, two we announced preclinical data on our Universal flu program sponsored by the N I E. A D demonstrating potential of the effect immune technology with computationally designed influenza proteins developed by the laboratory of Dr. Ted Ross I've been versus steel.
Roger.
The universal seasonal flu vaccine P. D S O to O two generated broadly protective anti influenza immune responses across multiple strains of influenza.
These data as well as our COVID-19 data has provided a unique opportunity to highlight and effective means potentially transformative utility in the development of more broadly effective and longer lasting protective vaccine.
We are hopeful that we could receive non dilutive financing from the NIH to progress our universal flu program into human clinical trials.
Based on the highly promising data recently announced with a universal flu vaccine and the current focus of the N I E. A D on developing more effective flu vaccine PD.
Tedious biotechnology has decided to strategically focus our near term infectious disease activities to align with the interests of the N I E I D.
To have a near term focus on influenza.
This will involve development of the universal seasonal flu vaccine and also potential development of a universal pandemic influenza vaccine based on similar computationally designed antigen as what has shown promise with infected.
The company had out license the COVID-19 vaccine P. D S O to O three to the Brazilian company pharma call specifically for development in Latin America.
The progression of the pharma co development program was delayed in the fourth quarter of 2021.
After review of the program by P. D S biotech and pharma cool.
Agreement with former Cole was extended through May 31st 2022 to provide additional time to form a cool to commence manufacturing and scale up of drug product, we used in clinical trials.
We have really if all the way to the progress of the program.
And as described above have determined to strategically focus our near term efforts on the development of the universal flu vaccine.
The licensing agreement with thermal coal will expire on may 31st 2022.
With that I'll now turn it over to Matt for a review of our financial results Matt.
Thank you Frank and thanks to all of you on the call today in this challenging environment. We currently find ourselves in we are truly grateful to our investors and analysts for their support and continued interest in the P. S biotech story.
For the first quarter ended March 31, 2020 to hear our summary financials.
Search and development expenses increased to approximately $5 $2 million for the three months ended March 31, 2022.
Approximately $1.4 million for three months ended March 31 2021.
The increase of approximately $3.7 million in 2022.
Was primarily attributed to.
Two an increase of $1.8 million in manufacturing services and quality costs $1 million in clinical and regulatory costs.
And $8 million in personnel costs.
General and administrative expenses increased to approximately $3.3 million for the three months ended March 31 2022.
From approximately $1.6 million for the three months ended March 31 2021.
The increase of approximately $1.7 million is primarily attributed to an increase of $1 million in personnel costs.
$6 million in legal fees.
And $1 million in marketing costs.
In April we were able to monetize monetize our net operating loss carryforwards.
And the state of New Jersey received $1.2 million from the net sale.
Tax benefits too and unbelief profitable, New Jersey corporations pursuant to the company's participation in the New Jersey technology business tax certificate transfer net operating loss program.
For fiscal year 2021.
We ended the quarter with $58 $9 million in cash.
Strong position, resulting from our partnering model and continuous financial discipline.
That we project will fund our operations into 'twenty 'twenty four.
With that why don't we open it up to questions operator.
Thank you, we'll now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue you.
You May press star two if you'd like to remove your question from the queue for participants using speaker equipment may be necessary to pick up your handset before pressing star one one moment. Please while we poll for questions.
Our first question today is coming from Louise Chen from Cantor Fitzgerald. Your line is now live.
Hi, congratulations on all the progress this quarter and thanks for taking my questions. So I had two questions for you first one is you know you talked about a lot of different programs and initiatives. So what are the pushes and pulls in your cash runway that you mentioned that goes through 2024, and then secondly, as you think about allocating.
Your resources, meaning both time and dollars how do you think about how you're going to do that with oncology and infectious disease being on the front burner. So to say thank you very much.
Louise Thanks, a lot for your questions. So addressing addressing the first one in terms of where we allocate our resources as we look at both oncology and infectious diseases with oncology as you see we have.
Institute.
T aggressive partnering program I think one of the things you probably realized compared to our peers is the quality of partners that we brought on to our programs, which we believe in addition to providing significant validation of the approach we've taken as Mark also said and as I said in the presentation. It's also very important.
In how we allocate our financial resources and the benefits that these partnerships have also provided to P. D. S. In terms of our ability to broadly cover the HPV cancer space and actually performed for clinical trials with PD is a one to one across all HPV cancer indications right. So this is really strong.
It was a very strategic approach for P. D. S. Very importantly, addressing this question of allocation of financial resources. So I prevent other than the Keytruda trial.
Where we are responsible for financially managing that trial, our partners, there's a significant cost sharing benefits with each of the other clinical trials right. So that approach is really what has allowed us to accomplish what we are doing today.
As we look forward to going into pivotal trials right part of what we will again do is determine how best and how financially.
How financially efficiently we can perform those pivotal trials right. So two key pivotal trials that we would want to start talking about and starting by waiting now I'll go through the trial as well as the Triple combination trial.
So those are key things that we will continue to update update folks on as we continue to progress those trials, but.
The partnership partnership agreements and partnership arrangements have been very significant and very important in allowing us to accomplish what we are accomplishing today.
And as we go into Pdfs are one three or one or two we don't want to spread ourselves too thin right. We also have to take keep shareholders in mind and ensure that we actually you see utilizing our shareholders investments judiciously.
And that's one key reason why we now focusing ongoing into pdfs of one to three which would be the first program beyond HPV cancer, and hopefully getting that IND filed by the end of this calendar year and against strategic can be one of the key things we would want to do this again.
Understand exactly how are we going to do that in terms of potential partnership or if we decide to finance that ourselves again designing a very efficient clinical trial approach and then subsequent to that looking at how best to progress P. D. S. A one or two which is also ready to go into human clinical trials potentially also important.
Partnership.
But these are key things that we're looking at very strategically and just making sure that we are able to create the most value financially efficiently.
And then as we progress into the into the infectious diseases with those activities also one of the key things that you may notice that we have really focused on utilizing non dilutive financing to progress our infectious disease programs right. The current program with the effect immune was funded by.
And with them, whether in fact, you mean and.
Universal seasonal universal flu antigens was funded by the NIH I D. And we are also looking to hopefully obtain some additional and I D or NIH funding to take that into human clinical trials. So when it comes to our capital resources. Our goal currently is really to dedicate those to the oncology.
Programs, which we believe will provide near term value creation to our shareholders in the company and really to focus.
Non dilutive funds on progressing there.
Infectious disease programs.
Lewis did that answer your questions.
Yes. It did thank you very much.
Youre welcome.
Thank you. Your next question today is coming from Leland <unk> from Oppenheimer. Your line is now live.
Hey, good morning, and thanks for taking my questions.
As we look forward to the upcoming data at <unk> just wanted to ask Frank you know longer term as we can.
Think about the development path for Pds, a one on one and any regulatory perspectives on how we should think about next steps for this development program on route to a potential BLA filing.
Hey, Leland. Thanks, so much for your questions. So for both programs one of the key things that we would want to do would be to have discussions with the F. D. A sooner than later probably sometime early in the third quarter to align on what the regulatory pathway would be for both programs for the Keytruda program.
The goal here as we mentioned is to really move the needle significantly in terms of the clinical benefit in improving the clinical benefit over what we see with Keytruda.
And also not compounding the taxes you said the data we've seen really to date in the first 18 patients. We believe is very significant in allowing us to potentially achieve that goal.
Hence in the clinical benefit without compounding the toxicities and that we believe would be very important and really position positioning this combination.
Very importantly, the ISO the oncologists, who are treating a lot of these patients and what we found out from a lot of the market research. We've done is how important safety is to be some colleges, especially with the earlier stage cancer patients right. So we believe if this continues and this progresses. It positions. This combination very very very favorably right.
And we anticipate that we will have to perform a controlled study and so those are some of the key things that we would want to discuss with the FDA in terms of what they would want to see in the control arm as we move into the pivotal trial.
With the Triple combination in one of the key things we've done is really.
In this case, we're looking at three investigational agents and one of the key questions that people have asked is how quickly are we going to move this into a pivotal trial based upon the data that we've seen today, which is really unprecedented.
And one of the key things I mentioned during the the.
During my portion of the call was the fact that the Nci's looking at high and low dose and H S out with one of the reason we're doing that is.
We believe very strongly and that the FDA will want to understand the role that each of these components. Each of these drugs is really playing in that Egypt, and the and confirmation that each of them has a significant role to play in contributing towards that.
The clinical.
But we see them.
And so to avoid going into a pivotal trial, where it wouldn't be looking at multiple arms looking at different combinations. We believe that its prudent to understand sooner than later to confirm sooner or later the role of each.
Each of these three components. So if you may recall after the first last year's <unk>. It became very clear the role that P. D. S. O. One O one was playing in the combination.
The NCI is doing now is looking at high and low dose and it's just that with 12 to try to tease out the role of NHS IL 12, and hopefully provide some confirmation of the important role that and it's just IL 12 display with a bindra, it's already been evaluated as a monotherapy in this exact same patient population right. So if we can go.
The FDA, making showing very clearly that each of these three agents is contributing significantly to the clinical outcomes that we're seeing it hopefully allows us to go in and perform a very focused and very quick pivotal trial and give this to commercialization sooner than later right. So that's the strategy that we've taken.
Hopefully.
Shortly after also to be able to sit down with the FDA and come to some alignment on what that regulatory strategy and Parkway would look like.
Great. Thank you, we look forward to the escrow presentations.
Welcome.
Thank you as a reminder, that star one to be placed in the question queue. Our next question is coming from Jim Molloy from Alliance Global Partners. Your line is now live.
Hello. This is Laura cereal, calling in for general I. Thank you for taking my question. So I'll follow up on the last question that was asked regarding the personal part one the triple combination trial of <unk> hundred one so when does the company have an overall idea when the completed enrollment might be finished for these two trials.
Follow up after.
After the Astro meeting that's coming up this summer or will not follow after the talks with the FDA that the company is planning to have any.
And as a second question are there any updates regarding the immunotherapy phase two trial of P. D. S. O. One O one and is the company still in line to obtain preliminary data for this trial mid year.
Kim.
Thanks, a lot for your question. So in terms of the first two trials and enrollment so stocking with a triple combination trial.
As of the last release, we made regarding enrollment the NCI had enrolled 35 patients and how to achieve the goal of enrolling 30 in the checkpoint inhibitor refractory are they have they have enrolled but I'm much more quickly than they have enrolled naive on them and so what they are doing now is enrolling all <unk>.
Immerse, both checkpoint inhibitor refractory and checkpoint inhibitor naive in order to get to their goal of 56 total patients quickly.
Last the last guidance. They gave US was that we anticipate to complete enrollment for that trial sometime during the summer.
I think that that's the last guidance that we received from the National Cancer Institute on that trial.
With the with the.
With the versatile zero-zero too that's a larger trial.
We anticipate basis.
I'm in recruitment as you know it is very difficult to predict predict so we are hoping or hopeful that we should be able to at least get to the end of the stage. The first time. So we have the checkpoint inhibitor naive, which started first in which we will be reporting on a costco and also the refractory all.
We are hopeful that we can make significant progress towards getting to the end of the recruitment hopefully early sometime early next year I think you said in the first stage, but what we want to do is to have discussions with the FDA based upon the current data that we have generated get a good understanding from the FDA how much more data they would want us to collect.
Whether they would want us to collect any more data and then make a decision as to what we do.
Moving forward, we will not be able to even if we make a transition to go to a pivotal trial, we will probably still have to keep this trial going just for ethical reasons to make sure that all of the patients get booked before.
Therefore treatments so at least.
It's a very good question, we saw some of the things. We are currently evaluating internally and some of the discussions we will be having with the FDA. So hopefully we will be able to provide you with some detail and some more solid solid decisions probably sometime in the third quarter regarding how this is going to progress.
And in terms of the immunotherapy UNICEF is still on track, we still anticipate providing updates and preliminary data sometime early in the third quarter of this year. So that's still on track.
Yeah.
Thank you. Our next question is coming from Robert Leboyer from Noble capital. Your line is now live.
Good morning.
My question has to do with the.
Influenza program.
And Oh.
I wanted to know if you have any time frames for filing an NDA or started in clinical trials.
Yeah.
No so with the influenza program, we have not received any.
Any details yet from the N I AIB, we know Doctor Ted Ross, it's working with them and we are we are hopeful that we will be able to receive some funding to go into human clinical trials, but until until that until we know for sure whether or not that's going to happen, it's very difficult to project.
Any IND filing dates a lot of it is it's really going to depend on whether or not we get the the fact, the funding to take it into human clinical trials and I think in our minds. We've made the decision that our capital resources will be focused on the oncology programs and so we're really going to be depending on dependent on non dilutive.
Financing to take that program into human clinical trial, we are quite hopeful, but I think the moment, we have some idea.
Whether that's going to happen or not and when it is going to happen. We will then be able to provide much more solid details on when the R&D filing will occur.
Okay, great. Thank you very much for that.
You're very welcome.
Thank you we reached end of our question and answer session I would like to turn the floor back over to management for any further or closing comments.
Okay. Thank you very much for joining us today, and we continue to look forward to updating all of you on our clinical and preclinical progress throughout the year and we will certainly be in touch shortly with more details about our data presentations and events surrounding <unk>.
In the meantime, we hope you have a great rest of the week and again. Thank you very much for all your support the company and thank you again for joining us today have a great day.
Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.